Cleared Traditional

K790746 - THE BIONIC EXERCISER

K790746 is an FDA 510(k) clearance for THE BIONIC EXERCISER, manufactured by Scudder Molner Instruments. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K790746 · Scudder Molner Instruments · Neurology device
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May 1979
Decision
28d
Days
Class 2
Risk

K790746 is an FDA 510(k) clearance for the THE BIONIC EXERCISER. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Scudder Molner Instruments (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K790746

510(k) Number K790746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1979
Decision Date May 14, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 170
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K790746.
V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU
K801049 · Nebulae Productions · Jun 1980
BIOFEEDBACK DEVICES & ACCESSORIES
K792115 · M.O.E Electronics Research & Prod. · Mar 1980
APOLLO HEART RATE INDICATOR
K791207 · Key Tronic Corp. · Aug 1979
VISUALAX
K781634 · Farrall Instruments, Inc. · Oct 1978
RELAX-A-TONE
K780436 · Bio Response · May 1978
CLINICAL EMG MODEL 133
K771577 · Calnor of EL Paseo, Inc. · Aug 1977
K790746 · THE BIONIC EXERCISER
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